Following the release of positive results for Phase III trial of ViiV Healthcare and GSK’s long-acting injectable antiretroviral treatment (ART) Cabenuva (cabotegravir + rilpivirine);

Barbora Salcman, Infectious Disease Analyst at GlobalData, offers her view:

“Cabenuva was approved by the FDA in January 2021, as a once monthly or once every other month complete HIV treatment regimen. It was also approved in the EU in October 2021 under the name Vocabria + Rekambys. While Cabenuva replaces the need for HIV patients to adhere to daily oral pills, it must be administered by a healthcare professional as a regimen of two intramuscular injections.

“Interim data from the Phase III LATITUDE study demonstrated the superior efficacy of Cabenuva in successfully maintaining viral load suppression in comparison to daily tablets in patients who had previously shown issues with adherence to ART. The full data of the interim study will be presented at an upcoming scientific conference.

“Cabenuva has already demonstrated positive efficacy results in previous clinical trials. For example, in the Phase III ATLAS clinical trial, Cabenuva met its primary endpoint, with 98% of participants having ≥50 copies of plasma HIV-1 RNA per milliliter after 48 weeks. The same results of 98% were observed in a control group who continued their current oral ART regimen. Furthermore, in the Phase IIIb SOLAR clinical trial, Cabenuva demonstrated similar efficacy in suppressing viral activity in comparison to Gilead’s Biktarvy (bictegravir sodium + emtricitabine + tenofovir alafenamide), a leading oral ART.

“Competition in the HIV field is fierce. The availability of numerous oral ARTs with strong efficacy and safety profiles means that patients can, for the most part, lead normal lives, and many patients are reluctant to switch to a new type of treatment if their current regimen is working well. However, a subgroup of patients still prevail that struggle to adhere to daily pills for numerous reasons. These include forgetting to take their daily medications, or worrying about others finding their medication due to the stigma that still often exists around HIV. As poor adherence is associated with drug resistance and disease progression, this subgroup could benefit greatly from injectables like Cabenuva, improving their quality of life and offering alternative treatment.

“The growth potential of long-acting injectables in HIV is strong. Overall, the longer the interval between dosing, the larger the patient shares these therapies are likely to gain, especially if they continue demonstrating superior efficacy. The appeal of long-acting injectables will increase further if patients can begin to self- administer these therapies, something that GSK is already investigating for Cabenuva.”